Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2025-12-26 @ 1:49 AM
Study NCT ID:
NCT05671705
Status:
COMPLETED
Last Update Posted:
2025-06-11
First Post:
2022-11-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Sarcopenia in Stroke Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D055948', 'term': 'Sarcopenia'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015502', 'term': 'Absorptiometry, Photon'}], 'ancestors': [{'id': 'D011859', 'term': 'Radiography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003720', 'term': 'Densitometry'}, {'id': 'D010783', 'term': 'Photometry'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 83}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-12-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-08', 'studyFirstSubmitDate': '2022-11-24', 'studyFirstSubmitQcDate': '2023-01-03', 'lastUpdatePostDateStruct': {'date': '2025-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of Modified Rankin Scale', 'timeFrame': '6 months from the first onset of the stroke', 'description': 'Functional Disability -\\> The scale runs from 0-6, running from perfect health without symptoms(0) to death(6).'}], 'secondaryOutcomes': [{'measure': 'Hand grip strength', 'timeFrame': 'within 4 weeks, 4 weeks, 8 weeks, 6 months from the first onset of the stroke', 'description': 'Grip strength: Grip strength will be measured using a dynamometer'}, {'measure': 'quadriceps muscle strength', 'timeFrame': 'within 4 weeks, 4 weeks, 8 weeks, 6 months from the first onset of the stroke', 'description': 'Lower extremity strength assessment:change in isometric quadriceps muscle strength (kg) from initial evaluation to the final evaluation'}, {'measure': 'Fugl-Meyer motor scale', 'timeFrame': 'within 4 weeks, 4 weeks, 8 weeks, 6 months from the first onset of the stroke', 'description': 'Motor function assessment : Fugl-Meyer motor scale from initial evaluation to the final evaluation (Upper Extremity maximum score = 66; Lower Extremity maximum score = 34, Higher score means better outcome)'}, {'measure': 'Functional Ambulation Category', 'timeFrame': 'within 4 weeks, 4 weeks, 8 weeks, 6 months from the first onset of the stroke', 'description': 'Gait function assessment : Functional Ambulation Category from initial evaluation to the final evaluation (Minimum 0, Maximum 5; Higher score means better outcome)'}, {'measure': 'Berg balance scale', 'timeFrame': 'within 4 weeks, 4 weeks, 8 weeks, 6 months from the first onset of the stroke', 'description': 'Balance function: change in Berg balance scale from initial evaluation to the final evaluation (Minimum score 0, Maximum score 56, Higher score means better outcome)'}, {'measure': 'Brain MRI', 'timeFrame': 'within 4 weeks and 6 months from the first onset of the stroke', 'description': 'Brain atrophy : change in the Global cortical atrophy scale(0-3) of the cerebral cortex from initial evaluation to the final evaluation'}, {'measure': 'Thigh Dixon MRI', 'timeFrame': 'within 4 weeks and 6 months from the first onset of the stroke', 'description': 'Muscle quality : muscle circumference measured by the thigh MRI from initial evaluation to the final evaluation'}, {'measure': 'Muscle ultrasonography', 'timeFrame': 'within 4 weeks and 6 months from the first onset of the stroke', 'description': 'muscle thickness(cm) measured by the ultrasound of the quadriceps muscle from initial evaluation to the final evaluation'}, {'measure': 'serum biomarkers for sarcopenia', 'timeFrame': 'within 4 weeks from the first onset of the stroke', 'description': 'BNDF, IL-6'}, {'measure': 'Digitalized SEMG signals', 'timeFrame': 'within 4 weeks, 4 weeks, 8 weeks, 6 months from the first onset of the stroke', 'description': 'state of the art EMG signals will be collected to assess muscle quality changes after stroke'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke', 'Sarcopenia']}, 'descriptionModule': {'briefSummary': 'Primary research purpose:\n\n-Prospective study to screen post stroke patients with sarcopenia and evaluate its effect on recovery\n\nSecondary research purpose:\n\n* To determine the degree of sarcopenia and correlation with poor functional prognosis of stroke in the stroke patient group.\n* To determine the degree of sarcopenia and correlation with dixon MRI of thigh muscle\n* To evaluate surface EMG (SEMG)-based signals and correlation with sarcopenia\n* To determine the degree of sarcopenia and correlation with brain morphometric changes', 'detailedDescription': 'Patients with first-ever stroke will be enrolled and assessed for sarcopenia. The evaluation parameters will include standard sarcopenia parameters and also SEMG-based signals and imaging studies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Recruited subjects will be allocated into 4 different groups according to presence of sarcopenia according to the Asian Working Group for Sarcopenia (2019) criteria.\n\n* Post stroke male patients with sarcopenia\n* Post stroke female patients with sarcopenia\n* Post stroke male patients without sarcopenia\n* Post stroke female patients without sarcopenia', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients 65 years of age or older, stroke patients with first onset within 4 weeks\n\nExclusion Criteria:\n\n* Patients who have not been evaluated for sarcopenia\n* Patients with neuromuscular diseases other than stroke that may affect gait function\n* Patients unable to conduct clinical trials according to instructions\n* Patients with uncontrolled medical/surgical disease\n* Patients with metal substances in the body such as cardiac pacemakers, cochlear implants, etc.\n* Patients who have difficulty collecting blood\n* Patients who are difficult to follow up after 6 months of onset due to moving to another area\n* Patients who have Parkinson's disease, dementia, or have a history of neuromuscular diseases such as Guillain-Barré syndrome or myasthenia gravis"}, 'identificationModule': {'nctId': 'NCT05671705', 'briefTitle': 'Effect of Sarcopenia in Stroke Patients', 'organization': {'class': 'OTHER', 'fullName': 'The Catholic University of Korea'}, 'officialTitle': 'Effect of Sarcopenia in Stroke Patients', 'orgStudyIdInfo': {'id': 'VC22ONDI0185'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Stroke patients with sarcopenia', 'description': 'Group will be stratified according to gender', 'interventionNames': ['Diagnostic Test: DEXA Scan']}, {'label': 'Stroke patients without sarcopenia', 'description': 'Group will be stratified according to gender', 'interventionNames': ['Diagnostic Test: DEXA Scan']}], 'interventions': [{'name': 'DEXA Scan', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Serum biomarkers, SEMG signals and MRI changes'], 'description': 'Fu of diagnostic tests', 'armGroupLabels': ['Stroke patients with sarcopenia', 'Stroke patients without sarcopenia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14647', 'city': 'Bucheon-si, Gyeonggi-do', 'country': 'South Korea', 'facility': 'The Catholic University of Korea'}, {'zip': '16247', 'city': 'Suwon', 'country': 'South Korea', 'facility': "St. Vincent's Hospital", 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Catholic University of Korea', 'class': 'OTHER'}, 'collaborators': [{'name': "Saint Vincent's Hospital, Korea", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD., PhD.', 'investigatorFullName': 'Sun Im', 'investigatorAffiliation': 'The Catholic University of Korea'}}}}